UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Title of the study (Brief title)	Endobiliary radiofrequency ablation for malignant biliary strictures
Region	Asia(except Japan)

Condition
Condition	Malignant biliary strictures by bile duct cancer, gallbladder cancer, or pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the safety and efficacy of endobiliary radiofrequency ablation (RFA) by using a new catheter in patients with malignant biliary strictures.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of early adverse events within 30 days after endobiliary radiofrequency such as hemobilia, bile duct perforation, pancreatitis, bleeding, cholangitis, perforation, or cholecystitis.
Key secondary outcomes	Late adverse events after 30 days after endobiliary radiofrequency, stent patency of biliary metallic stent after endobiliary radiofrequency ablation, and patient survival after endobiliary radiofrequncy ablation.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Endobiliary radiofrequency ablation by using a new catheter and biliary metallic stenting through ERCP
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) More than 19 in age 2) Extrahepatic malignant biliary stricture that was histophathologically or clinically confirmed 3)Unresectable or inoperable due to comorbidity or refusal of operation 4) More than 3 months of predictive survival
Key exclusion criteria	1) Contraindications for ERCP 2) Uncontrolled coagulopathy: PT-INR > 1.5 (normal 0.85 - 1.25) or platelet count < 60,000/mm3 (normal 150,000 - 450,000/mm3) 3) Previously operation of bile duct 4) Impossible to access to the ampulla of Vater or failed selective biliary cannulation 5) Pregnant or breastfeeding women 6) Refusal to the study
Target sample size	100

Research contact person
Name of lead principal investigator	Hyun Jong Choi
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Address	170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL	+82-32-621-5211
Email	joseph@schmc.ac.kr

Public contact
Name of contact person	Hyun Jong Choi
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Address	170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL	+82-32-621-5211
Homepage URL
Email	joseph@schmc.ac.kr

Sponsor
Institute	Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Institute
Department

Funding Source
Organization	Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 25 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 25 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029721